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Trial registered on ANZCTR


Registration number
ACTRN12611000423910
Ethics application status
Approved
Date submitted
28/02/2011
Date registered
27/04/2011
Date last updated
4/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Most Simple and Safe Way to Place Nasogastric Tube Under Anesthesia: A Randomized, Prospective Study
Scientific title
A randomized, prospective study comparing four techniques for placing nasogastric (NG) tubes in anesthetized patients to determine which technique is the most simple, fast, safe, and successful
Secondary ID [1] 259695 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients ASA I to III who received general anesthesia for various surgeries that required NG tube placing. 261269 0
Condition category
Condition code
Anaesthesiology 259421 259421 0 0
Other anaesthesiology
Surgery 259422 259422 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Over160 patients between 20 and 70 yr old who had to receive general anesthesia for various surgeries that required nasogastric (NG) tube insertion were enrolled in the study.
Patients were divided into four groups. First, the control group where patients had NG tube inserted directly through a nostril with head in the neutral position. In the second group NG tube was tied to an intubating stylet by a slipknot before insertion. The third group patients had their neck flexed and a lateral pressure was applied over neck while NG tube placing. In the last group NG tube insertion was facilitated by simply lifting-forward displacement- of the larynx. Number of attempts, success rate, duration of insertion, and different complications were observed and recorded.
Intervention code [1] 264124 0
Prevention
Intervention code [2] 264125 0
Treatment: Devices
Comparator / control treatment
In the control group patients had NG tube inserted directly through a nostril with head in the neutral position
Control group
Active

Outcomes
Primary outcome [1] 266628 0
Successful NG tube insertion was confirmed if the tube passed smoothly and a gurgling sound was heard on auscultation over the epigastrium when injecting of air through the NG tube. In Group C, successful NG tube insertion at first attempt was achieved in 9 (22.5%) patients. The success rates of NG insertion were greater in Groups F, L, and S: 24 patients (60.0%), 34 patients (85.0%), 37 patients(92.5%) respectively.
Timepoint [1] 266628 0
during NGT insertion
Primary outcome [2] 266629 0
If the first attempt failed, the NG tube was withdrawn fully and the procedure was repeated using the same technique. If both attempts at insertion using the selected technique were unsuccessful, then the technique was considered a failure. In Group C overall success was recorded in 17 patients (42.5%), while overall success rates for group F, L, and S were 31 patients (77.5%), 38 patients (95.0%), and 39 patients (97.5%) respectively.
Timepoint [2] 266629 0
during NGT insertion
Primary outcome [3] 266631 0
Total NG tube insertion time was 46.2 +/-26.4s in Group C, and this time was significantly shorter in Group L ( 25.3+/- 22.2), but not so different from the time required in Group F (39.1 +/- 25.5) and S (42.6 +/-25.7).
Timepoint [3] 266631 0
time required for NGT insertion with each technique
Secondary outcome [1] 273847 0
The most common complication was kinking which occurred in 19 patients (47.5%) of Group C, 13 patients of Group F (32.5), and 6 patients of group L (15%). Kinking was not a problem in Group S where intubating stylet provided enough stiffness to the NGT preventing kinking of the tube as much as possible.
Timepoint [1] 273847 0
while NG tube insertion
Secondary outcome [2] 276110 0
There were no statistically significant differences in the demographic data (age, gender, and body weight or body height ) of the four patient groups.
Timepoint [2] 276110 0
during this randamized prospective study.

Eligibility
Key inclusion criteria
study included 160 patients aged from 20 to 70 who received general anesthesia for various surgeries that required NG tube placing.
Minimum age
20 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients under 20 yr or older than 70 yr
2. Severe coagulopathy
3. Severe nasoseptal deviation
4. Patient or family refusal

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Hospital ethical committee approval was obtained and a valid written informed consent was obtained for each patient. The patients were randomly allocated into four groups according to a computer generated randomization order.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The patients were randomized into four groups, control group, lifting of larynx, neck flexion with lateral pressure, and intubating stylet guided.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/08/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
160
Accrual to date
Final
Recruitment outside Australia
Country [1] 3243 0
Taiwan, Province Of China
State/province [1] 3243 0
Taoyuan

Funding & Sponsors
Funding source category [1] 264584 0
Hospital
Name [1] 264584 0
Chang Gung Memorial Hospital.
Country [1] 264584 0
Taiwan, Province Of China
Primary sponsor type
Hospital
Name
Chang Gung Memorial Hospital
Address
Chang Gung Memorial Hospital. 5, Fu-Shin Street, Kweishan, Taoyuan, Taiwan
Country
Taiwan, Province Of China
Secondary sponsor category [1] 263929 0
None
Name [1] 263929 0
Address [1] 263929 0
Country [1] 263929 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260569 0
Chang Gung Medical Foundation Human Research Ethics Committee
Ethics committee address [1] 260569 0
Ethics committee country [1] 260569 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 260569 0
Approval date [1] 260569 0
19/10/2009
Ethics approval number [1] 260569 0
98-2669B

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32284 0
Address 32284 0
Country 32284 0
Phone 32284 0
Fax 32284 0
Email 32284 0
Contact person for public queries
Name 15531 0
Amina Illias
Address 15531 0
Department of anesthesiology
Chang Gung Memorial Hospital. 5, Fu-Shin Street, Kueishan, Taoyuan, Taiwan
Country 15531 0
Taiwan, Province Of China
Phone 15531 0
886975366367
Fax 15531 0
886-3-328-2173
Email 15531 0
aminaillias@hotmail.com
Contact person for scientific queries
Name 6459 0
Amina Illias
Address 6459 0
Department of anesthesiology
Chang Gung Memorial Hospital. 5, Fu-Shin Street, Kueishan, Taoyuan, Taiwan
Country 6459 0
Taiwan, Province Of China
Phone 6459 0
886975366367
Fax 6459 0
Email 6459 0
aminaillias@hotmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AINasogastric tube insertion in anesthetized and intubated patients: a new and reliable method2012https://doi.org/10.1186/1471-230x-12-99
Dimensions AIA comparison of nasogastric tube insertion techniques without using other instruments in anesthetized and intubated patients2013https://doi.org/10.5144/0256-4947.2013.476
N.B. These documents automatically identified may not have been verified by the study sponsor.